ARTFX MEDICAL Cervical PEEK Cages— 510(k) K240893

Name: FDA 510(k) clearance K240893
Creator: U.S. Food and Drug Administration
Published: 2024-06-28

Substantially Equivalent

Artfx Medical

FDA 510(k) clearance K240893 for ARTFX MEDICAL Cervical PEEK Cages, Substantially Equivalent on 2024-06-28. Applicant: Artfx Medical. Device class: 2.

Clearance details

Applicant: Artfx Medical
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2024-04-01
Decision date: 2024-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

view all

K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Artfx Medical

view all

K242939 — ARTFX Trauma Bone Plate and Screw System2024-12-23
K240889 — ARTFX Lumbar PEEK Cages2024-10-02

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.